Purpose

This randomized phase III trial studies bortezomib, lenalidomide, and dexamethasone to see how well they work compared to carfilzomib, lenalidomide, and dexamethasone in treating patients with newly diagnosed multiple myeloma. Bortezomib and carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may help the immune system kill abnormal blood cells or cancer cells. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether bortezomib, lenalidomide, and dexamethasone are more or less effective than carfilzomib, lenalidomide, and dexamethasone in treating patients with multiple myeloma

Category

IRB Number
20150407HU
NCT Number
NCT01863550
Open to Enrollment
Yes
Sponsor
ECOG-ACRIN Cancer Research Group -



Study Contact

Principal Investigator
Matthew Butler

Matthew Butler
(210) 203-8047
ButlerMJ@uthscsa.edu

Frances Crawford
(210) 450-5037
crawfordf1@uthscsa.edu

Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu

Myrna Montenegro
(210) 450-5954
montenegro@uthscsa.edu

Courtney Nichols
(210) 450-1794
nicholsc2@uthscsa.edu

Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu

Regulatory Staff
regaffstaff@uthscsa.edu

Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu

Benjamin Schleif
(210) 450-1366
schleifb@uthscsa.edu

Morgan Seekatz
(210) 450-1133
seekatz@uthscsa.edu



Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    Exclusion Criteria


      Study Design

      Phase
      Phase 3
      Study Type
      Interventional
      Allocation
      Randomized
      Intervention Model
      Parallel Assignment
      Primary Purpose
      Treatment
      Masking
      None (Open Label)
      Condition
    1. Plasma Cell Myeloma
    2. Arm Groups

      ArmDescriptionIntervention
      Experimental

      Arm A (bortezomib, lenalidomide, dexamethasone)

      Patients receive bortezomib SC or IV on days 1, 4, 8, and 11 of courses 1-8 and days 1 and 8 of courses 9-12; lenalidomide PO daily on days 1-14; and dexamethasone PO daily on days 1, 2, 4, 5, 8, 9, 11, and 12 of courses 1-8 and days 1, 2, 8, and 9 of courses 9-12. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
    3. Other: Laboratory Biomarker Analysis

      Optional correlative studies

    4. Other: Quality-of-Life Assessment

      Ancillary studies

      Other names:

      • Quality of Life Assessment

    5. Drug: Bortezomib

      Given SC or IV

      Other names:

      • [(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid
      • LDP 341
      • MLN341
      • PS-341
      • PS341
      • Velcade

    6. Drug: Dexamethasone

      Given PO

      Other names:

      • Aacidexam
      • Adexone
      • Aknichthol Dexa
      • Alba-Dex
      • Alin
      • Alin Depot
      • Alin Oftalmico
      • Amplidermis
      • Anemul mono
      • Auricularum
      • Auxiloson
      • Baycuten
      • Baycute

    7. Drug: Lenalidomide

      Given PO

      Other names:

      • CC-5013
      • CC5013
      • CDC 501
      • Revlimid

    8. Experimental

      Arm C (lenalidomide)

      Patients receive lenalidomide PO daily on days 1-21. Treatment repeats every 4 weeks for 24 courses in the absences of disease progression or unacceptable toxicity.
    9. Other: Laboratory Biomarker Analysis

      Optional correlative studies

    10. Other: Quality-of-Life Assessment

      Ancillary studies

      Other names:

      • Quality of Life Assessment

    11. Drug: Lenalidomide

      Given PO

      Other names:

      • CC-5013
      • CC5013
      • CDC 501
      • Revlimid

    12. Experimental

      Arm B (carfilzomib, lenalidomide, dexamethasone)

      Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16; lenalidomide PO daily on days 1-21; and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 4 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.
    13. Drug: Carfilzomib

      Given IV

      Other names:

      • Kyprolis
      • PR-171

    14. Other: Laboratory Biomarker Analysis

      Optional correlative studies

    15. Other: Quality-of-Life Assessment

      Ancillary studies

      Other names:

      • Quality of Life Assessment

    16. Drug: Dexamethasone

      Given PO

      Other names:

      • Aacidexam
      • Adexone
      • Aknichthol Dexa
      • Alba-Dex
      • Alin
      • Alin Depot
      • Alin Oftalmico
      • Amplidermis
      • Anemul mono
      • Auricularum
      • Auxiloson
      • Baycuten
      • Baycute

    17. Drug: Lenalidomide

      Given PO

      Other names:

      • CC-5013
      • CC5013
      • CDC 501
      • Revlimid

    18. Experimental

      Arm D (lenalidomide)

      Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
    19. Other: Laboratory Biomarker Analysis

      Optional correlative studies

    20. Other: Quality-of-Life Assessment

      Ancillary studies

      Other names:

      • Quality of Life Assessment

    21. Drug: Lenalidomide

      Given PO

      Other names:

      • CC-5013
      • CC5013
      • CDC 501
      • Revlimid